Impact protection for implantable electric lead

ABSTRACT

A novel implantable electric lead arrangement is described for medical implant systems such as middle ear implants (MEI), cochlear implants (CI) and vestibular implants (VI). An electric lead contains parallel lead wires wound in an elongated helix about a central longitudinal axis. A lead core is fixed and enclosed within the wire helix for providing impact strain relief to the lead wires by resisting radial and/or axial deformation from external impact force.

This application claims priority from U.S. Provisional PatentApplication 61/756,502, filed Jan. 25, 2013, which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to medical implants, and more specificallyto an implantable electrode arrangement used in medical implant systemssuch as middle ear implants (MEI), cochlear implants (CI) and vestibularimplants (VI).

BACKGROUND ART

A normal ear transmits sounds as shown in FIG. 1 through the outer ear101 to the tympanic membrane (eardrum) 102, which moves the bones of themiddle ear 103 (malleus, incus, and stapes) that vibrate the oval windowand round window openings of the cochlea 104. The cochlea 104 is a longnarrow duct wound spirally about its axis for approximately two and ahalf turns. It includes an upper channel known as the scala vestibuliand a lower channel known as the scala tympani, which are connected bythe cochlear duct. The cochlea 104 forms an upright spiraling cone witha center called the modiolar where the spiral ganglion cells of theacoustic nerve 113 reside. In response to received sounds transmitted bythe middle ear 103, the fluid-filled cochlea 104 functions as atransducer to generate electric pulses which are transmitted to thecochlear nerve 113, and ultimately to the brain.

Hearing is impaired when there are problems in the ability to transduceexternal sounds into meaningful action potentials along the neuralsubstrate of the cochlea 104. To improve impaired hearing, auditoryprostheses have been developed. For example, when the impairment isrelated to operation of the middle ear 103, a conventional hearing aidmay be used to provide acoustic-mechanical stimulation to the auditorysystem in the form of amplified sound. Or when the impairment isassociated with the cochlea 104, a cochlear implant with an implantedelectrode contact can electrically stimulate auditory nerve tissue withsmall currents delivered by multiple electrode contacts distributedalong the electrode.

FIG. 1 also shows some components of a typical cochlear implant systemwhich includes an external microphone that provides an audio signalinput to an external signal processor 111 where various signalprocessing schemes can be implemented. The processed signal is thenconverted into a digital data format, such as a sequence of data frames,for transmission into the implant 108. Besides receiving the processedaudio information, the implant 108 also performs additional signalprocessing such as error correction, pulse formation, etc., and producesa stimulation pattern (based on the extracted audio information) that issent through an electrode lead 109 to an implanted electrode array 110.Typically, this electrode array 110 includes multiple stimulationcontacts 112 on its surface that provide selective stimulation of thecochlea 104.

The electrode array 110 contains multiple lead wires embedded in a softsilicone body referred to as the electrode carrier. The electrode array110 needs to be mechanically robust, and yet flexible and of small sizeto be inserted into the cochlea 104. The material of the electrode array110 needs to be soft and flexible in order to minimize trauma to neuralstructures of the cochlea 104. But an electrode array 110 that is toofloppy tends to buckle too easily so that the electrode array 110 cannotbe inserted into the cochlea 104 up to the desired insertion depth.

U.S. Patent Publication 2010/0305676 (“Dadd,” incorporated herein byreference) describes winding the lead wires in the extra-cochlearsegment of the electrode lead in a helical shape to make that portion ofthe electrode lead stronger. Dadd is quite clear that such a helicalportion does not extend into the intra-cochlear electrode array whichneeds to be much more flexible than the extra-cochlear lead in order tominimize trauma to the cochlear tissues when the array is inserted.

U.S. Patent Publication 2010/0204768 (“Jolly,” incorporated herein byreference) describes winding the individual lead wires in theintra-cochlear electrode array in an elongated helical shape where eachwire is separate and independent.

Electrode leads of active implantable medical devices including MiddleEar Implants (MEI's), Cochlear Implants (CI's), Brainstem Implants(BI's) and Vestibular Implants (VI's) need to be small in diameter butalso they carry multiple lead wires. Electrode leads also need to berobust against external mechanical impacts, especially in locationswhere the electrode lead is placed on top of the skull bone only coveredby the skin. In case of a mechanical impact on an unprotected electrodelead, the elastic silicone electrode carrier material is compressed andthe electrode lead becomes temporarily locally thinner and elongated.Lead wires at the affected location experience local tensile forces andcan even break. This is also the case for helically formed wires withina silicone electrode carrier since they are forced to expand nearly thesame amount as the carrier material itself.

To deal with this problem, some implant designs arrange for theelectrode lead to exits the implantable processor housing so that theelectrode lead never lies superficially on top of bone. One disadvantageof such designs in the case of cochlear implants is that the implanthousing must be placed in a very exactly defined position relative tothe ear. For implant designs where the electrode lead emerges from theside of the implant housing, the surgeon is recommended to drill anelectrode channel into the bone, which is time consuming so that notevery surgeon follows the recommendations. Some electrode lead designinclude a rigid impact protector that surrounds the electrode lead, butthat approach reduces the flexibility of the electrode lead which inturn makes the surgical implantation procedure more difficult. And incase of a mechanical impact in the area of the electrode lead, a rigidimpact protector may protect the electrode from damage but also maycause trauma in the surrounding tissue when it is pressed against theprotector.

SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to an implantableelectric lead arrangement. While the following description uses thespecific example of a cochlear implant electrode lead connected at oneend to an implantable cochlear implant processor and connected atanother end to an intracochlear electrode array, one of skill in thefield will understand that the invention is not limited to thatparticular specific context and is more broadly understood as any sortof implantable electric lead for medical implant systems—such as middleear implants (MEI), cochlear implants (CI), brainstem implants (BI), andvestibular implants (VI)—that connects different units of such animplant system such as an implantable microphone or other sensor withanother device in the system.

An electric lead contains parallel lead wires wound in an elongatedhelix about a central longitudinal axis. A lead core is fixed andenclosed within the wire helix for providing impact strain relief to thelead wires by resisting radial and/or axial deformation from externalimpact force.

The lead core may be made of a flexible polymer material, which may havean elastic module value and/or a shore-A hardness value greater thansome given threshold value. Or the lead core may be made of a flexiblemetallic material, bundled fibers, or bundled wires. The lead core mayhave a rod shape or a conical shape. The lead core may have a diameterless than 0.7 times the diameter of the electric lead. The helix shapemay have a diameter less than 1.5 times the diameter of the lead core.Some embodiments may also have support ribs that are perpendicular tothe lead core and distributed along the length of the lead core. Theelectric lead may specifically be a cochlear implant electrode leadconnected at one end to an implantable cochlear implant processor andconnected at another end to an intracochlear electrode array

Embodiments of the present invention also include an implantableelectric lead arrangement for a medical implant system, including anelectric lead that contains parallel lead wires wound in an elongatedhelix about a central longitudinal axis. At least one support wire isparallel to the lead wires and has a higher strain energy absorptioncapacity than the lead wires to mechanically strengthen the lead wiresagainst external impact force.

There may be multiple support wires, for example, one along each outerside of the helical ribbon of lead wires. The at least one support wireand the lead wires of the helical ribbon may form a single integratedstructural element. Or the at least one support wire and the lead wiresmay be structurally separate elements wound together in a helicalribbon.

Embodiments of the present invention also include an implantableelectric lead arrangement for a medical implant system in which anelectric lead contains parallel lead wires wound in an elongated helixabout a central longitudinal axis. An impact protection ribbon is woundcoaxially with the lead wires in an elongated helical ribbon about acentral longitudinal axis and mechanically protects the lead wires fromexternal impact force.

The impact protection ribbon may be made of fluorinated ethylenepropylene (FEP), polyethylene, poly-etheretherketone (PEEK) material orsuperelastic Nitinol material. The impact protection ribbon may becoaxially outside or coaxially inside the lead wires. The electric leadmay specifically be a cochlear implant electrode lead connected at oneend to an implantable cochlear implant processor and connected atanother end to an intracochlear electrode array

Embodiments of the present invention also include an implantableelectric lead arrangement for a medical implant system, in which anelectric lead contains parallel lead wires wound in an elongated helixabout a central longitudinal axis and a wire support substrate in aplane beneath the lead wires that mechanically supports the lead wiresand protects the lead wires from external impact force. The lead wiresand the wire support substrate are wound in an elongated helical ribbonabout a central longitudinal axis.

The wire support substrate may be made, for example, of fluorinatedethylene propylene (FEP), polyethylene or poly-etheretherketone (PEEK)material. The wire support substrate may be molded around the lead wiresor glued to the lead wires. The electric lead may specifically be acochlear implant electrode lead connected at one end to an implantablecochlear implant processor and connected at another end to anintracochlear electrode array

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows anatomical structures in a human ear having a cochlearimplant system.

FIG. 2 shows the local effect of a mechanical impact force on a portionof an implantable electric lead.

FIG. 3 shows an embodiment of the present invention having a conicallead core.

FIG. 4 shows an embodiment of the present invention having a rod-shapedlead core with support ribs.

FIG. 5 shows an embodiment of the present invention with support wiresalong each outer edge of the helical wire ribbon.

FIG. 6 shows an embodiment of the present invention with a supportsubstrate beneath the helical wire ribbon.

FIG. 7 shows an embodiment of the present invention having a hollow leadcore.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

FIG. 2 shows how longitudinal deformation of a cochlear implantelectrode lead 109 occurs in response to radial and/or axial deformationcaused by an external impact or exerted pressure onto the electrode lead109 which thins and elongates the resilient material of the lead carrier201 and creates a local tensile force on the lead wires 202. Suchlongitudinal deformation should be prevented or strongly suppressed.Reduced longitudinal deformation as a response to radially induceddeformation is especially a challenge in electric leads 109 havinghelically wound lead wires 202 as in FIG. 2. Embodiments of the presentinvention are directed to an implantable electric lead, for example, acochlear implant electric lead 109, which is more robust against radialand/or axial deformation to avoid wire breakage within the electric lead109. This most often occurs relatively close to the stimulator housingwhere after implantation the electric lead 109 runs on top of the skullbone.

FIG. 3 shows one embodiment where an electric lead 300 which has an leadcarrier material 304 that contains parallel embedded lead wires 301. Asshown in FIG. 3, the lead wires 301 are wound in an elongated helixabout a central longitudinal axis of the electrode lead 300. Theembedded lead wires 301 may also be arranged in other suitable formsthan in an elongated helix. For example, the lead wires 301 may beshaped in a substantially sinusoidal form about a central longitudinalaxis of the electric lead 300.

A conical lead core 302 is fixed and enclosed in the lead carrier 304within the wire helix for providing impact strain relief to the leadwires 301 by resisting radial and/or axial deformation from externalimpact force. The lead core 302 may be made of a flexible polymermaterial that may have an elastic module value and/or a shore-A hardnessvalue greater than some given threshold value. For example, the leadcarrier 304 material may be silicone of medium shore-A hardness (e.g.NUSIL MED-4244 or Applied Silicone LSR40), while the lead core 302material may have a higher shore-A hardness (e.g. NUSIL MED-4770).

In other specific embodiments, the lead core 302 may be made of aflexible metallic material, for example, a shape memory alloy (SMA) suchas Nitinol. The flexible metallic material may be a single wire having athickness e.g. between 0.4 mm and 0.1 mm, or more preferably between 0.3mm and 0.2 mm. Or the lead core 304 may be formed from bundled fibers orwires which may run in parallel or be braided. Lead core fibers may bemade of inorganic materials such as carbon basalt (e.g. CBF—continuousbasalt fibers) or glass, or from organic materials such aspolypropylene, polyethylene, polyamide, aramide, spun liquid crystalpolymer (e.g. Vectran) or other materials from these groups.Alternatively, they may be made from shape memory alloy such as Nitinol,e.g. having a bundle thickness between 0.4 mm and 0.1 mm, or morepreferably between 0.3 mm and 0.2 mm. The material of the lead core 302resists elongation of the electric lead 300 in case of a mechanicalimpact and also restricts diametric compression of the electric lead300.

Whatever the specific choice of the material of the lead core 302, theflexibility of the electric lead 300 should be preserved. It isimportant that the surgeon can be able to bend the electric lead 300 toproperly implant it, for example, to insert the electric lead 300through the holed drilled into the skull bone, preferably as easily aswithout this core element 302 being present.

To satisfy the competing requirements of mechanical strength and impactresistance versus high flexibility suggests that it is important tochoose an intelligent set of ratios between the radii of the variouselements of the electric lead 300. For example, the ratio between thelead core 302 radius (r_(C)) and the electric lead 300 radius (r_(L))may be selected to be greater than 0.1 and less than 0.7:0.1<r_(C)/r_(L)<0.7. In a preferred embodiment this ratio maybe between0.33<r_(C)/r_(L)<0.66. In addition, the ratio between the radius of thehelical shape of the lead wires 301 (r_(H)) and the lead core 302 radius(r_(C)) should be selected to be between 1+x and 1.5, where x is theratio between the radius of the lead wires 301 themselves (includingisolation) and the lead core 302 (r_(C)). (A ratio between the radii ofthe wire helix (r_(H)) and the core (r_(C)) represents the value of 1+xwhen the lead wires 301 are directly wound around the lead core 302). Ina preferred embodiment, the ratio r_(H)/r_(C) may be between 1+x and1.3,, or even more preferably between 1+x and 1.25.

The conical end 303 of the lead core 302 ensures that there is not anabrupt transition of mechanical lead properties between theimpact-protected part of the electric lead 300 and the unprotected part.Where the lead core 302 is made of individual wires or fibers, each ofthese may extend by different amounts towards the conical end 303 toprovide a smooth transition.

FIG. 4 shows structural elements of an embodiment of a rod shaped leadcore 302 with support ribs 305 that are perpendicular to the lead core302 and distributed along the length of the lead core 302. The supportribs 305 help anchor the lead core 302 within the lead carrier 304material and also help resist radial and/or axial deformation fromexternal mechanical impacts on the electric lead 300.

In contrast to some previous schemes for temporarily using a stiffenerelement to assist with surgical insertion of the electrode, which isthen removed, the lead core 302 element is securely fixed within thelead carrier 304 and remains as a structural element of the electriclead 300 after surgery to provide lasting post-surgical protection fromexternal impacts. Moreover, proper design of the lead core 302 and theelectric lead 300 should maintain full flexibility of the electric lead300 rather than making it stiffer for surgical handling as with theprior art schemes. In addition, the prior art intra-surgical stiffenerelement is designed to be placed at the cochleostomy opening (or otherlocation where the lead may be buckled during insertion), whereas thelead core 302 is placed close to the basal end of the electric lead 300near the implant housing where it runs relatively unprotected aftersurgery on top of skull bone. It is also worth noting that the prior artsurgical stiffener element does not describe how to deal with lead wires301 that wound in an elongated helical shape embedded within an leadcarrier 304 as here.

Embodiments of the present invention also include other specificapproaches for mechanically protecting the lead wires. FIG. 5 show animplantable electric lead arrangement for a medical implant system wherean electric lead 500 has a lead carrier 503 which contains parallelembedded lead wires 501. As shown in FIG. 5, the lead wires 501 arewound in an elongated helix about a central longitudinal axis of theelectric lead 500. The embedded lead wires 501 may also be arranged inother suitable forms than in an elongated helix, for example, the leadwires 501 may be shaped in a substantially sinusoidal form about acentral longitudinal axis of the electric lead 500.

At least one support wire 502 is parallel to the lead wires 501 and hasa higher strain energy absorption capacity than the lead wires 501 tomechanically strengthen the lead wires 501 against external impactforce. In the specific embodiment shown in FIG. 5, there are multiplesupport wires 502, one along each outer side of the helical ribbon oflead wires 501. The at least one support wire 502 and the lead wires 501of the helical ribbon may form a single integrated structural element,or they may be structurally separate elements wound together in ahelical ribbon. In order to absorb the tensile forces acting on the leadwires 501 in the case of a mechanical impact onto the electric lead 500,the support wires 502 may be thicker and/or may be made of a differentmaterial (e.g. different metallic alloy, manufactured fiber or polymer)than the lead wires 501.

Embodiments of the present invention also include an implantableelectric lead arrangement for a medical implant system such as the oneshown in FIG. 6. An electric lead 600 has a lead carrier 603 thatcontains parallel embedded lead wires 601. As shown in FIG. 6, the leadwires 601 are wound in an elongated helix about a central longitudinalaxis of the electric lead 600. The embedded lead wires 601 may also bearranged in other suitable forms than in an elongated helix, forexample, the lead wires 601 may be shaped in a substantially sinusoidalform about a central longitudinal axis of the electric lead 600.

A impact protection ribbon 602 lies in a plane beneath the lead wires601 acting as a wire support substrate that mechanically supports thelead wires 601 and protects the lead wires 601 from external impactforce. The lead wires 601 and the impact protection ribbon 602 are woundtogether in an elongated helical ribbon about a central longitudinalaxis of the electric lead 600. The impact protection ribbon 602 may bemade of thermoplastic material, fluorinated ethylene propylene (FEP),polyethylene or poly-etheretherketone (PEEK) material, which may bemolded around the lead wires 601 or glued to the lead wires 601 to forma wire support substrate.

In some embodiments, the impact protection ribbon 602 may not be fixedconnected to the lead wires and thus does not act as a wire supportsubstrate. Rather, the impact protection ribbon 602 may be woundcoaxially but separately with the lead wires 601 in an elongated helicalribbon about a central longitudinal axis of the electric lead 600 andmechanically protects the lead wires 601 from external impact force. Insuch embodiments, the impact protection ribbon 602 may be coaxiallyoutside or coaxially inside the lead wires 601 and may be made offluorinated ethylene propylene (FEP), polyethylene,poly-etheretherketone (PEEK) material or superelastic Nitinol material.

FIG. 7 shows an embodiment similar to that of FIG. 3 but without ahollow core element 700. The lead wires 701 are wound in an elongatedhelix about a central longitudinal axis of the electric lead andembedded in a hollow cylinder of core material 702. The embedded leadwires 701 may also be arranged in other suitable forms than in anelongated helix, for example, the lead wires 701 may be embedded in corematerial 702 and shaped in a substantially sinusoidal form about acentral longitudinal axis of the electric lead. A hollow lead core 700reduces the overall volume of silicone in the electric lead and soreduces the amount of silicone displaced in a longitudinal directionduring an impact. As a result the longitudinal pulling forces on thelead wires 701 during an impact are reduced, leading to better impactresistance. FIG. 7 shows the approximate relative proportions of ahollow core for an implant electrode. The ratio of hollow core toelectrode lead diameter should be about the same as proposed above.

Embodiments of the present invention such as those described aboveprovide protection of an implantable electric lead against mechanicalimpact with lower risk of lead wire breakage in case of such mechanicalimpacts. And despite the increased robustness of the electric leadagainst a mechanical impact, the elasticity and flexibility of theelectric lead are less electric lead. Depending on the specific corematerial used, the electric lead can be elastic (to flip back afterbeing bent), malleable (to retain the new shape when bent), or floppy.Although additional components and manufacturing steps are needed incomparison to an unprotected electric lead, the still uncomplicatedelectrode structures allow for easy manufacturing processes.

Although various exemplary embodiments of the invention have beendisclosed, it should be apparent to those skilled in the art thatvarious changes and modifications can be made which will achieve some ofthe advantages of the invention without departing from the true scope ofthe invention.

What is claimed is:
 1. An implantable electric lead arrangement for amedical implant system, the arrangement comprising: an implantableelectric lead having a desired bending flexibility and containing aplurality of parallel lead wires wound in an elongated helix about acentral longitudinal axis; and i. a lead core fixed and enclosed withinthe wire helix in a portion of the electric lead without altering thedesired bending flexibility of the electric lead and configured forproviding impact strain relief to the portion of the electric lead byresisting radial and/or axial deformation from external impact force. 2.The implantable electric lead arrangement according to claim 1, whereinthe lead core is made of a flexible polymer material.
 3. The implantableelectric lead arrangement according to claim 2, wherein the polymermaterial has an elastic module value greater than some given thresholdvalue.
 4. The implantable electric lead arrangement according to claim2, wherein the polymer material has a shore-A hardness value greaterthan some given threshold value.
 5. The implantable electric leadarrangement according to claim 1, wherein the lead core is made of aflexible metallic material.
 6. The implantable electric lead arrangementaccording to claim 1, wherein the lead core is formed from bundledfibers.
 7. The implantable electric lead arrangement according to claim1, wherein the lead core is formed from bundled wires.
 8. Theimplantable electric lead arrangement according to claim 1, wherein thelead core has a rod shape.
 9. The implantable electric lead arrangementaccording to claim 1, wherein the lead core has a conical shape.
 10. Theimplantable electric lead arrangement according to claim 1, furthercomprising: a plurality of support ribs perpendicular to the lead coreand distributed along the length of the lead core.
 11. The implantableelectric lead arrangement according to claim 1, wherein the lead corehas a diameter less than 0.7 times the diameter of the electric lead.12. The implantable electric lead arrangement according to claim 11,wherein the helix shape has a diameter less than 1.5 times the diameterof the lead core.
 13. The implantable electric lead arrangementaccording to claim 1, wherein the electric lead is a cochlear implantelectrode lead connected at one end to an implantable cochlear implantprocessor and connected at another end to an intracochlear electrodearray.